Research Supports Key Areas of Clinical Development for electroCore’s Vagus Nerve Stimulator

electroCore Inc., a global commercial-stage bioelectronic medicine company, has announced new preclinical and clinical research supporting the potential therapeutic benefit of its non-invasive vagus nerve stimulator (nVNS), gammaCore, for the treatment of mild traumatic brain injury (mTBI) and rheumatoid arthritis (RA). 
 
“The recent results are very encouraging as they support the broad therapeutic potential of nVNS therapy,” said Francis Amato, CEO of electroCore. “Based on these data, gammaCore could represent a safe and effective non-drug treatment option for patients with mild traumatic brain injury and rheumatoid arthritis. We look forward to further validating nVNS for treatment of these conditions as we remain committed to leveraging our unmatched expertise and proprietary technology to expand the applicability of nVNS and provide patients with an effective, non-drug treatment option for a growing number of diseases and disorders.”
 
Results from a preclinical study evaluating nVNS for the prevention and treatment of comorbid mTBI and post-traumatic stress disorder (PTSD) demonstrate the potential use of therapeutic nVNS following blast-induced mTBI, a condition for which there is currently no effective treatment option. electroCore plans to initiate a pilot trial to further evaluate the effects of nVNS on the prevention of post-traumatic headache in the second half of 2019.
 
Results from electroCore’s first human trial evaluating the effect of short-term transcutaneous nVNS on disease activity and pro-inflammatory cytokines in RA provide preliminary support for an anti-inflammatory effect. The company also plans to initiate a randomized controlled trial to further evaluate the efficacy of nVNS for the treatment of RA in the second half of 2019.
 
gammaCore (nVNS) is the first non-invasive, hand-held medical therapy cleared by the U.S. Food and Drug Administration (FDA) as an adjunctive therapy for the preventative treatment of cluster headache and as an acute treatment for pain associated with episodic cluster headache and migraine headache in adult patients. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers leading to a modulation of neurotransmitters and a reduction in pain.
 
gammaCore is the only therapy that is FDA-cleared for the prevention of cluster headache.
 
gammaCore (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation on the side of the neck. gammaCore is indicated for:
 

• Adjunctive use for the preventive treatment of cluster headache in adult patients.
• The acute treatment of pain associated with episodic cluster headache in adult patients.
• The acute treatment of pain associated with migraine headache in adult patients. 

 
The safety and effectiveness of gammaCore have not been established in the acute treatment of chronic cluster headache, nor has it shown to be effective for preventing migraine headaches.
 
The long-term effects of the chronic use of gammaCore have not been evaluated. It is not indicated for:

• Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
• Pediatric patients
• Pregnant women
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

Patients also should not use gammaCore if they have a metallic device such as a stent, bone plate, or bone screw implanted at or near their neck, and/or they ae using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone).
 
electroCore Inc. is a commercial-stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology and rheumatology. The company’s initial targets are the preventative treatment of cluster headache and acute treatment of migraine and episodic cluster headache.